Xabitor 2.5/Xabitor 5 Special Precautions

Conditions with increased risk of hemorrhage e.g., congenital or acquired bleeding disorders, active ulcerative GI disease, bacterial endocarditis, thrombocytopenia, platelet disorders, history of hemorrhagic stroke, severe uncontrolled HTN, & recent brain, spinal or ophthalmic surgery. Not recommended in patients with hepatic disease associated with coagulopathy & clinically relevant bleeding risk; undergoing hip fracture surgery; prosthetic heart valves with or without atrial fibrillation. Discontinue if severe hemorrhage occurs. Temporarily discontinue for active bleeding, elective surgery, or invasive procedures; avoid lapses in therapy & restart as soon as possible. Risk of developing spinal or epidural hematoma during spinal/epidural anesthesia or puncture which can result in long-term or permanent paralysis. Indwelling epidural or intrathecal catheters must be removed at least 5 hours prior to the 1st dose. Frequently monitor for signs & symptoms of neurological impairment. Not recommended as an alternative to unfractionated heparin for the initial treatment of patients with PE who present with hemodynamic instability or who may receive thrombolysis of pulmonary embolectomy. Not recommended for patients with history of thrombosis who are diagnosed with antiphospholipid syndrome. Carefully assess patients with atrial fibrillation & conditions that warrants mono or dual antiplatelet therapy. Concomitant use with strong CYP3A4 & P-gp inhibitors eg, azole-antimycotics (eg, ketoconazole, itraconazole, voriconazole & posaconazole), HIV PIs (eg, ritonavir); strong CYP3A4 & P-gp inducers (eg, rifampin, phenytoin, carbamazepine, phenobarbital or St. John's wort); antiplatelet agents; NSAIDs including ASA; other platelet aggregation inhibitors or other antithrombotic agents. Not recommended in patients with CrCl <15 mL/min or those undergoing dialysis, or with severe hepatic impairment. Mild or moderate hepatic impairment (Child Pugh A or B). Not recommended during pregnancy. Lactation. Children <18 yr.